PINNACLE POROCOAT 1217-01-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295008613), received between Mar 13, 2019 and Jun 29, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR FAILED RIGHT TOTAL HIP REPLACEMENT SECONDARY TO METALLOSIS, ELEVATED METAL LEVELS IN THE BLOOD STREAM, TROCHANTERIC BURSITIS WITH METAL DEBRIS, AND SYNOVITIS OF THE RIGHT HIP. OPERATIVE NOTES REPORTED, THAT THERE WAS A VERY WHITE TISSUE WITH A SLIGHT GRAYISH HUE SUGGESTIVE OF METAL DEBRIS. THERE WAS SOME PERIACETABULAR HETEROTOPIC BONE THAT WAS PRESENT WHICH WAS RESECTED. THERE WAS SOME BLACKENED DEBRIS AROUND THE JUNCTION OF THE MORSE TAPER AND THE FEMORAL HEAD. MORSE TAPER HAD ONLY MILD DULLING OF THE SURFACE OR BURNISHING. POST OPERATIVE FINDINGS REPORTED THAT A GRAY METALLOSIS FROM COBALT CHROME, BLACKENING AROUND THE BALL TO MORSE TAPER JUNCTION AS THE SOURCE OF THE METAL DEBRIS. IT WAS ALSO REPORTED THAT THERE WAS A SMALL DEHISCENCE WAS NOTED IN THE CAPSULE POSTERIOR SUPERIORLY. DOI: (B)(6) 2004; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Calcium Deposits/Calcification; Foreign Body Reaction; No Code Available

  MAUDE report 10209500 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS INFECTION. PAIN AND SWELLING WERE ALSO NOTED. REVISION NOTES REPORTED GROSS PURULENCE; NO METALLOSIS, SIGNIFICANT WEAR NOR METAL DEBRIS WERE FOUND. IT WAS STATED THAT THE PATIENT HAD A SUPERFICIAL INFECTION IN HIS ARM THAT SUBSEQUENTLY SPREAD TO HIS HIP. IT WAS ALSO NOTED THAT POST INITIAL HIP REPLACEMENT, THE PATIENT WAS ADMITTED DUE TO POST OP INFECTION DUE TO A SUPERFICIAL WOUND INFECTION THEN WAS TREATED WITH I&D AND 3 WEEKS OF IV ANTIBIOTICS. DOI: (B)(6) 2009; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9627664 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF HAS NO ALLEGATION REPORTED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS INFECTION AND FAILURE OF SKIN HEALING ON THE RIGHT LATERAL HIP. REVISION NOTE REPORTED OF MURKY FLUID WITHIN THE JOINT ITSELF SURROUNDED WITH THICK YELLOW PUS. THE SURGEON WAS ALSO REPORTED OF RESIDUAL METALLIC DEBRIS AND ALVAL TISSUE IN THE POSTERIOR MEDIAL FEMORAL CORTEX. DOI: (B)(6) 2013; DOR: (B)(6) 2013, (RIGHT HIP) FOURTH REVISION.

  Patient problems: No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 8596233 ↗
• InjuryMar 13, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND A POPPING/SNAPPING SENSATION. **UPDATE: 10/18/2012 RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF INFECTION. ** PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN, DISCOMFORT, AND INFECTION. **UPDATE** 10/24/2013- X-RAYS RECEIVED AND PUT IN FILE. -AK. UPDATE REC'D 5/12/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE AD 26 FEB 2019: RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGED PSEUDOTUMOR. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL HIP ARTHROPLASTY, INCREASING PAIN IN THE LEFT HIP, PATIENT HAD A WORKUP, WHICH WAS CONSISTENT WITH LOOSENING. PATIENT EXPERIENCED PAIN, LOOSENING OF THE PROSTHESIS, AND SUBSIDENCE. OPERATIVE REPORTED THERE WAS SCARRING WITHIN SUPERFICIAL AND DEEP TISSUES.

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Joint Disorder; No Code Available; Pain; Scarring; Tissue Damage; Unspecified Infection

  MAUDE report 8416155 ↗